Cardiac adverse events associated with lacosamide: a disproportionality analysis of the FAERS database.
Lacosamide
/ adverse effects
Humans
Adverse Drug Reaction Reporting Systems
/ statistics & numerical data
Female
Male
Databases, Factual
Middle Aged
Anticonvulsants
/ adverse effects
United States
/ epidemiology
Adult
Aged
United States Food and Drug Administration
Adolescent
Young Adult
Cardiotoxicity
/ etiology
Cardiac adverse events
Disproportionality analyses
FAERS database
Lacosamide
Reporting odds ratio
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
13 Jul 2024
13 Jul 2024
Historique:
received:
29
09
2023
accepted:
09
07
2024
medline:
14
7
2024
pubmed:
14
7
2024
entrez:
13
7
2024
Statut:
epublish
Résumé
Lacosamide was the first approved third-generation antiepileptic drug. However, real-world data regarding its adverse cardiac reactions in large samples still need to be completed. We evaluated the cardiac safety profile of lacosamide using the Food and Drug Administration Adverse Event Reporting System (FAERS). We performed disproportionality analysis computing reporting odds ratio (ROR) as a quantitative metric to assess the signal of lacosamide-related cardiac adverse events (AEs) from 2013 Q1 to 2022 Q4. The signal was considered significant when the lower limit of the 95% confidence interval (CI) of the ROR exceeded 1, and ≥ 5 AEs were reported. Serious and nonserious cases were compared by statistical analysis, and signals were further prioritized using a rating scale. A total of 812 cardiac AEs associated with lacosamide were identified, and 92 signals were detected, of which 17 AEs were significantly associated signals. The median time-to-onset (TTO) for moderate priority signals was 10 days, whereas for weak priority signals, it was 54 days. Notably, all cardiac AEs exhibited an early failing pattern, indicating the risk gradually decreasing. Based on the comprehensive analysis of the FAERS database and prioritization of cardiac AE signals, our research enhances the awareness among healthcare professionals regarding cardiac AEs associated with lacosamide.
Identifiants
pubmed: 39003359
doi: 10.1038/s41598-024-67209-0
pii: 10.1038/s41598-024-67209-0
doi:
Substances chimiques
Lacosamide
563KS2PQY5
Anticonvulsants
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
16202Subventions
Organisme : Key Scientific and Technology Project of Henan Province
ID : 222102310358
Informations de copyright
© 2024. The Author(s).
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